Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 7:19 PM
Study NCT ID:
NCT00923559
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2009-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mother-Infant Psychoanalysis Project of Stockholm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bjorn.salomonsson@ki.se', 'phone': '+46851777206', 'title': 'Björn Salomonsson', 'organization': "Dept of Women's and Children's Health, Karolinska Institutet"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The assumption that assignment to Treatment As Usual (TAU) at Child Health Centres (CHC) would generate disappointment was contradicted: pre-treatment data were more optimal in this group. The final number of non-completers was roughly equal in the two treatment groups.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Mothers were invited to contact the investigator about any adverse events. The follow-up interviews 6 months after the first thoroughly investigated adverse effects.', 'eventGroups': [{'id': 'EG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety.", 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TAU at Child Health Centres', 'description': 'Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centre', 'description': 'Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.53', 'groupId': 'OG000', 'lowerLimit': '79.56', 'upperLimit': '87.50'}, {'value': '76.67', 'groupId': 'OG001', 'lowerLimit': '72.74', 'upperLimit': '80.60'}]}]}], 'analyses': [{'pValue': '.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '8.69', 'ciLowerLimit': '2.64', 'ciUpperLimit': '14.74', 'pValueComment': 'Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\\<.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.04', 'groupDescription': 'Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom (df) = 68.3'}], 'paramType': 'MEAN', 'timeFrame': 'Two interviews, six months apart', 'description': 'An observer-rated scale ranging from 0 to 99, from "documented maltreatment" to "well-adapted". Higher scores indicate a better outcome. Inter-rater reliability was measured with an external experienced infant psychotherapist.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Outliers (z-transformed scores\\>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used."}, {'type': 'PRIMARY', 'title': 'the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centres', 'description': 'Treatment as usual with nurse visits at Child HEalth Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.28', 'groupId': 'OG000', 'lowerLimit': '4.82', 'upperLimit': '7.74'}, {'value': '7.99', 'groupId': 'OG001', 'lowerLimit': '6.56', 'upperLimit': '9.43'}]}]}], 'analyses': [{'pValue': '.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.57', 'ciLowerLimit': '0.46', 'ciUpperLimit': '4.68', 'pValueComment': 'p-value unadjusted for multiple comparisons. A priori threshold p\\<.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'groupDescription': 'Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom (df) = 69.3'}], 'paramType': 'MEAN', 'timeFrame': 'Two interviews, six months apart', 'description': 'The EPDS (Swedish translation, Lundh \\& Gylland, 1990), is a self-report questionnaire containing 10 items each with a 3-point scale. Range: 0 - 30. Higher scores indicate a worse outcome. It is widely used at Swedish CHCs and has been validated on samples in Sweden.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Outliers (z-transformed scores\\>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used."}, {'type': 'PRIMARY', 'title': 'the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-infant Psychoanalytic Treatment; MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centres', 'description': 'Treatment as usual with nurse visits at Child HEalth Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.24'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '1.37'}]}]}], 'analyses': [{'pValue': '.266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.75', 'pValueComment': 'p-value unadjusted for multiple comparisons. A priori threshold p\\<.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom = 73.4'}], 'paramType': 'MEAN', 'timeFrame': 'Two interviews, six months apart', 'description': 'Items are mostly rated on a 4-step scale, with 0,5,10 or 15 points per item, where 0 is most optimal. There are three versions for the age ranges of this study: 3-8, 9-14, and 15-20 months. To enable comparison across age groups we report mean scores across all items. Higher scores indicate a worse outcome. Each version was independently translated into Swedish, retranslated and approved by the constructor.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Outliers (z-transformed scores\\>3.29) were replaced by raw scores corresponding to z=3.29.Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used."}, {'type': 'SECONDARY', 'title': 'the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centres', 'description': 'Treatment as usual with nurse visits at Child HEalth Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '2.85'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '2.57', 'upperLimit': '2.91'}]}]}], 'analyses': [{'pValue': '.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.32', 'pValueComment': 'p-value unadjusted for multiple comparisons. A priori threshold p\\<.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Two interviews six months apart', 'description': 'A Swedish-language version of the Parenting Stress Index (PSI; Abidin, 1990) with 35 items, each ranging 1-5 points. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Outliers (z-transformed scores\\>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used."}, {'type': 'SECONDARY', 'title': 'the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-infant Psychoanalytic Treatment; MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centres', 'description': 'Treatment as usual with nurse visits at Child HEalth Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'see under the PIR-GAS', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom (df) = 61.2'}], 'paramType': 'MEAN', 'timeFrame': 'Two interviews, six months apart', 'description': "The EAS assessed video-taped mother-baby interactions of 10' duration on three maternal dimensions (Sensitivity, Structuring, Non-intrusiveness) and two infant dimensions (Responsiveness and Involvement. The raw scores of the subscales have different ranges (0-5, 0-7, and 0-9). To enable comparison across subscales, we divided scores in each subscale with its maximal score. This yielded a range for each subscale of 0-1.Thus, the total score range for all subscales was 0-1, with higher scores indicating a better outcome. Here we report results on Sensitivity.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Outliers (z-transformed scores\\>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used."}, {'type': 'SECONDARY', 'title': 'General Severity Index of the Symptom Check List-90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety."}, {'id': 'OG001', 'title': 'Treatment as Usual at Child Health Centre', 'description': 'Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.71'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.83'}]}]}], 'analyses': [{'pValue': '.158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Degrees of freedom (df) = 71.2'}], 'paramType': 'MEAN', 'timeFrame': 'two assessments at six month-interval', 'description': 'The Symptom Check List-90 (SCL-90; Derogatis, 1994), with a Swedish language version (Fridell, Cesarec, Johansson, \\& Malling Thorsen, 2002), is a self-report questionnaire containing 90 items rated from 0 to 4. Higher scores indicate a worse outcome. The General Severity Index (GSI, or the mean across all items) was used to measure maternal general psychological distress.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety."}, {'id': 'FG001', 'title': 'TAU at Child Health Centres', 'description': 'Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mother-Infant Psychoanalytic Treatment;MIP', 'description': "MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety."}, {'id': 'BG001', 'title': 'TAU at Child Health Centres', 'description': 'Scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2009-06-17', 'resultsFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-27', 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)', 'timeFrame': 'Two interviews, six months apart', 'description': 'An observer-rated scale ranging from 0 to 99, from "documented maltreatment" to "well-adapted". Higher scores indicate a better outcome. Inter-rater reliability was measured with an external experienced infant psychotherapist.'}, {'measure': 'the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)', 'timeFrame': 'Two interviews, six months apart', 'description': 'The EPDS (Swedish translation, Lundh \\& Gylland, 1990), is a self-report questionnaire containing 10 items each with a 3-point scale. Range: 0 - 30. Higher scores indicate a worse outcome. It is widely used at Swedish CHCs and has been validated on samples in Sweden.'}, {'measure': 'the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002', 'timeFrame': 'Two interviews, six months apart', 'description': 'Items are mostly rated on a 4-step scale, with 0,5,10 or 15 points per item, where 0 is most optimal. There are three versions for the age ranges of this study: 3-8, 9-14, and 15-20 months. To enable comparison across age groups we report mean scores across all items. Higher scores indicate a worse outcome. Each version was independently translated into Swedish, retranslated and approved by the constructor.'}], 'secondaryOutcomes': [{'measure': 'the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997)', 'timeFrame': 'Two interviews six months apart', 'description': 'A Swedish-language version of the Parenting Stress Index (PSI; Abidin, 1990) with 35 items, each ranging 1-5 points. Higher scores indicate a worse outcome.'}, {'measure': 'the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998)', 'timeFrame': 'Two interviews, six months apart', 'description': "The EAS assessed video-taped mother-baby interactions of 10' duration on three maternal dimensions (Sensitivity, Structuring, Non-intrusiveness) and two infant dimensions (Responsiveness and Involvement. The raw scores of the subscales have different ranges (0-5, 0-7, and 0-9). To enable comparison across subscales, we divided scores in each subscale with its maximal score. This yielded a range for each subscale of 0-1.Thus, the total score range for all subscales was 0-1, with higher scores indicating a better outcome. Here we report results on Sensitivity."}, {'measure': 'General Severity Index of the Symptom Check List-90', 'timeFrame': 'two assessments at six month-interval', 'description': 'The Symptom Check List-90 (SCL-90; Derogatis, 1994), with a Swedish language version (Fridell, Cesarec, Johansson, \\& Malling Thorsen, 2002), is a self-report questionnaire containing 90 items rated from 0 to 4. Higher scores indicate a worse outcome. The General Severity Index (GSI, or the mean across all items) was used to measure maternal general psychological distress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mother-infant Relational Disturbances']}, 'referencesModule': {'references': [{'pmid': '17244571', 'type': 'BACKGROUND', 'citation': 'Salomonsson B. "Talk to me baby, tell me what\'s the matter now". Semiotic and developmental perspectives on communication in psychoanalytic infant treatment. Int J Psychoanal. 2007 Feb;88(Pt 1):127-46. doi: 10.1516/04p3-fuer-0u41-lln8.'}, {'pmid': '17908677', 'type': 'BACKGROUND', 'citation': 'Salomonsson B. Semiotic transformations in psychoanalysis with infants and adults. Int J Psychoanal. 2007 Oct;88(Pt 5):1201-21. doi: 10.1516/ijpa.2007.1201.'}, {'pmid': '28543080', 'type': 'BACKGROUND', 'citation': 'Salomonsson B, Sleed M. The Ages & Stages Questionnaire: Social-Emotional: A validation study of a mother-report questionnaire on a clinical mother-infant sample. Infant Ment Health J. 2010 Jul;31(4):412-431. doi: 10.1002/imhj.20263.'}, {'type': 'BACKGROUND', 'citation': 'Salomonsson, B. (2009). Mother-infant work and its impact on psychoanalysis with adults. Scandinavian Psychoanalytic Review, 32, 3-13.'}, {'pmid': '28520149', 'type': 'BACKGROUND', 'citation': 'Salomonsson B. The music of containment: Addressing the participants in mother-infant psychoanalytic treatment. Infant Ment Health J. 2011 Nov;32(6):599-612. doi: 10.1002/imhj.20319. Epub 2011 Nov 3.'}, {'pmid': '26908296', 'type': 'RESULT', 'citation': 'Salomonsson B, Sandell R. A randomized controlled trial of mother-infant psychoanalytic treatment: I. Outcomes on self-report questionnaires and external ratings. Infant Ment Health J. 2011 Mar;32(2):207-231. doi: 10.1002/imhj.20291.'}, {'pmid': '26904966', 'type': 'RESULT', 'citation': 'Salomonsson B, Sandell R. A randomized controlled trial of mother-infant psychoanalytic treatment: II. Predictive and moderating influences of qualitative patient factors. Infant Ment Health J. 2011 May;32(3):377-404. doi: 10.1002/imhj.20302.'}], 'seeAlsoLinks': [{'url': 'http://www.bjornsalomonsson.se', 'label': 'Describes the research project and its clinical utility in lay language'}]}, 'descriptionModule': {'briefSummary': 'Mother-infant relationship disturbances broadly comprise three areas; maternal distress, infant functional problems, and relationship difficulties. Given the high frequency of such disturbances and the relative paucity of randomized treatment studies, substantial systematic investigation is needed. This project is a randomized controlled study comparing mother-infant psychoanalytic treatment with treatment as usual in cases where mothers and/or health visitors demanded expert help.', 'detailedDescription': 'DESIGN\n\nEighty dyads with infants below 1½ years of age were interviewed and then randomly assigned to MIP or TAU. An end-point interview followed after ½ year, evaluating the intervention effects.\n\nThe MIP treatments were performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society. TAU implied contact with a nurse at a Child Health Centre, as part of regular Swedish health care of infants and mothers. Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother were registered at the end-point interview.\n\nINSTRUMENTS\n\nMother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the General Severity Index of the Symptom Check List-90 (Derogatis, 1994)and the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997).\n\nTime frame: All four instruments were measured at intake interviews and six months later.\n\nIndependently rated video-taped mother-infant interactions: the Emotional Availability Scale (EAS; Biringen, 1998).\n\nRelationship assessment: the Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant\'s well-being, or the mother-baby relationship (this was operationalized as a score \\< 80 ("perturbed relation") on the PIR-GAS or, alternatively, \\> 2.5 on the SPSQ).\n* Infant of any gender, age below 18 months.\n* Duration of worries exceeding two weeks.\n* Domicile in Stockholm.\n* Reasonable mastery of Swedish.\n\nExclusion Criteria:\n\n* Maternal psychosis.\n* Substance dependence according to DSM-IV, to an extent precluding collaboration.\n\nNo mothers met these criteria.'}, 'identificationModule': {'nctId': 'NCT00923559', 'acronym': 'MIPPS', 'briefTitle': 'Mother-Infant Psychoanalysis Project of Stockholm', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)', 'orgStudyIdInfo': {'id': 'MIPPS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mother-Infant Psychoanalytic treatment;MIP', 'description': 'MIP intervention', 'interventionNames': ['Other: Mother-Infant Psychoanalytic treatment (MIP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU at Child Health Centres', 'description': 'Regular nurse visits at Child Health Centres according to Swedish infant health care.', 'interventionNames': ['Other: Treatment as Usual at Child Health Centre']}], 'interventions': [{'name': 'Treatment as Usual at Child Health Centre', 'type': 'OTHER', 'description': 'Treatment as usual (TAU) involved scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers might be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the TAU framework, additional treatment might be initiated by the nurse or the mother. This was registered at the end-point interview.', 'armGroupLabels': ['TAU at Child Health Centres']}, {'name': 'Mother-Infant Psychoanalytic treatment (MIP)', 'type': 'OTHER', 'description': "MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. In the study, the analysts strived to recruit the baby for an emotional interchange, though this did not imply any belief that the infant would understand verbal communication. Rather, the analyst addressed the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst took care in enrolling the participant mother. This was to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety.", 'armGroupLabels': ['Mother-Infant Psychoanalytic treatment;MIP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Per-Anders Rydelius, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doct. student', 'investigatorFullName': 'Bjorn Salomonsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}